June 28, 2011
Thank you for the opportunity to testify today. I am Dr. Diana Zuckerman, president of the National Research Center for Women & Families and our Cancer Prevention and Treatment Fund. I am also a fellow at the University of Pennsylvania Center for Bioethics.
My perspective is as a scientist trained in epidemiology at Yale Medical School, a former faculty member at Yale and Vassar, and a researcher at Harvard. I am also speaking as someone who has lost dear friends to breast cancer.
I strongly support the FDA’s decision to rescind approval of Avastin for Stage 4 breast cancer. I also want to be respectful and supportive of breast cancer patients who are currently on Avastin and seem to be benefiting.
The FDA took a risk when it provided an accelerated approval for Avastin based on preliminary data. The data now support reversing that decision and I believe it would having a chilling effect on the FDA if it were politically impossible for them to do that. It would make it much less likely for the FDA to take a chance on promising new drugs in the future if they knew that they couldn’t reverse their decision if better studies indicated that a product’s risks outweigh the benefits.
We’ve heard wonderful stories today from women who have had very good experiences after taking Avastin. But, the research tells us that for each woman who had a wonderful experience, there was at least one and perhaps two women who had a very bad experience – who died or suffered from stroke or other painful or debilitating adverse reactions to the drugs. I am here to testify on their behalf as well.
That’s why the FDA needs to rescind approval for Avastin – because on average, women do not benefit in terms of living longer or having a better quality of life. In fact, women taking Avastin tend to live less long and have a poor quality of life because of adverse reactions. However, women who are currently on Avastin and seem to be benefiting deserve our attention. Since the company has made a great deal of money selling Avastin to breast cancer patients and others, Genentech should make Avastin available for free to breast cancer patients who are currently taking it and are doing well. Genentech should study those women and other women so that the company can determine why some breast cancer patients benefit from Avastin while others are harmed by it. Genentech should then re-submit an application to the FDA to ask for approval for the subgroup of breast cancer patients who are most likely to benefit from the drug and much less likely to be harmed by it.
It’s unfortunate that Genentech hasn’t yet focused their attention on figuring out which patients will benefit and which will be harmed. That’s the reason why the FDA needs to rescind approval at this time. Of course, Avastin would should be available to breast cancer patients who need it. If Genentech does its part, breast cancer patients who are currently benefiting from Avastin will be able to stay on the drug.